Recall Z-0813-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Outset Medical, Inc.
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
| Date | Jan 20, 2022 |
| Status | Open, Classified |
| Reason | Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. |
| Root cause | Device Design |
| Action | On 01/20/2022, the firm send a "MEDICAL DEVICE FIELD ACTION" Letter to customers informing them that Outset Medical is proactively replacing a component on the Talbo Hemodialysis consoles due to the possibility of heat-related damage that may occur to the Tablo device. Outset Medical has identified that Tablo Hemodialysis Systems manufactured between July 6, 2018 and November 24, 2021 require the component replacement. Outset is indicating that the replacement will be completed within the next twelve months during the next routine maintenance or at the next service call. Outset Field Servic |
| Quantity | 1,123 systems (PN-0003000) and 1,487 (PN-0006000) |
| Distribution | U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. |
| FDA record | Open on fda.gov |